Company Profile for Iris Pharma

A leading contract research organization (CRO) dedicated to
ophthalmology, Iris Pharma partners with clients to carry out
preclinical and clinical studies involving all areas of the field, from
the ocular surface – such as dry eye syndrome – to the posterior segment
of the eye – including age-related macular degeneration and diabetic
retinopathy.

“Our focus in this niche market allows us to guide our clients in making
the best decisions to move their products from the laboratory to humans
as quickly, safely, and effectively as possible,” says CEO Pierre-Paul
Elena, PhD. “From its founding nearly 25 years ago, we have based the
company on and expanded our expertise in the science of ophthalmology.”

Clients range from small start-ups to large pharmaceutical companies.
Some have years of experience in ophthalmology, and others are new to
the field, eager to apply their backgrounds in related disciplines such
as diabetes or oncology. Recent clients have also included companies
looking to translate drugs developed for use outside the eye to an
ocular application, as well as those concerned about possible ocular
side effects or toxicity caused by drugs for other uses.

“We are experts in helping our partners from the moment they have a
problem or question involving the eye,” Dr. Elena explains.

Iris Pharma has facilitated the translation of more than 40 ocular drugs
and medical devices from the laboratory to marketing approval in Europe,
the United States, and around the world of by carrying out nearly 2,200
preclinical studies and 100 clinical trials. The company is able to do
this as efficiently as possible by maintaining a global view of the
ophthalmology drug and device development process.

“We are thinking of humans from the moment we begin testing in animals,”
Dr. Elena says.

The use of nearly 50 in vivo models – the largest number on the market
– to mimic the human eye’s conditions for preclinical studies and in
vivo screening.

Development, customization, and validation of drugs and their
metabolites in biological matrices through bioanalytical tests,
including determining the dosage of very small quantities of product
in the microstructures of the eye.

Facilitation and acceleration of Phase I to IV clinical trials and
marketing surveys that meet the appropriate regulatory requirements.

Recruitment of patients with appropriate characteristics: more than
24,000 patients and 3,700 clinical sites have been involved throughout
Europe and North Africa.

Strategic consulting regarding the direction of drug development, the
design of a study, and the best indication for molecules in
development.

To support more than 230 clients worldwide, Iris Pharma maintains a
GLP-accredited laboratory for preclinical research and bioanalytical
testing, and conducts high-quality clinical trials in accordance with
ICH GCP guidelines.

“At Iris Pharma, we value customer service, high-quality data, accurate
results, and innovative technologies,” Dr. Elena says. “Ultimately, our
mission is to advance the field of ophthalmology and to help maintain
the eye health of patients, whether it involves ocular-specific drugs or
ancillary medical products that may have an impact on the eye.”